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Pre-Sure 1

by Lazarus 3D 2 variants

Pre-Sure 1 is a Class II device made by Lazarus 3D, listed in FDA GUDID since 8 Sep 2023 (UDI-DI G18910), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG18910 UDI-DI Date8 Sep 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Pre-Sure
Generic name
Radiology information system application software
Model / reference
1
Primary DI / UDI-DI
G18910
FDA product code
LLZ
GMDN term
Radiology information system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiology information system application software

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Lazarus 3D

  • Pre-Sure 1

    Class II

  • Pre-Sure

    Class II

  • Pre-Sure

    Class II

Properties

  • Single use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)